Methods for anchoring a device at a native heart valve annulus

ABSTRACT

A method and device for anchoring a prosthetic heart valve or annuloplasty ring to a valve annulus in a heart and a method of implanting same is disclosed. The device can include a prosthetic valve or annuloplasty ring with one or more anchors configured to be threaded or otherwise passed underneath a native leaflet and/or subvalvular tissue to secure the device at the native annulus.

RELATED APPLICATIONS

The present application is a divisional of U.S. application Ser. No.15/482,529, filed Apr. 7, 2017, which is a continuation of U.S.application Ser. No. 14/797,163, filed Jul. 12, 2015, which is adivisional of U.S. application Ser. No. 13/675,801, filed Nov. 13, 2012,now issued as U.S. Pat. No. 9,078,747, which claims priority to U.S.Provisional Application No. 61/578,758, filed Dec. 21, 2011, all ofwhich are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The current invention generally relates to heart valve repair andreplacement devices and methods. More specifically, the currentinvention is directed to anchoring devices and methods for prostheticheart valves and annuloplasty rings configured for rapid implantationand methods for implanting same.

BACKGROUND OF THE INVENTION

The heart is a hollow muscular organ of a somewhat conical form; it liesbetween the lungs in the middle mediastinum and is enclosed in thepericardium. The heart rests obliquely in the chest behind the body ofthe sternum and adjoining parts of the rib cartilages, and typicallyprojects farther into the left than into the right half of the thoraciccavity so that about one-third is situated on the right and two-thirdson the left of the median plane. The heart is subdivided by septa intoright and left halves, and a constriction subdivides each half of theorgan into two cavities, the upper cavity being called the atrium, thelower the ventricle. The heart therefore consists of four chambers; theright and left atria, and right and left ventricles, with one-way flowvalves between respective atria and ventricles and at the outlet fromthe ventricles.

The atrioventricular heart valves (i.e., the tricuspid and mitralvalves) are located in the center of the heart between the atria and theventricles of the heart, and play important roles in maintaining forwardflow of blood. Atrioventricular valve dysfunction is also commonly knownas “regurgitation” and affects well over one million people globally.The mitral and tricuspid valves are defined by fibrous rings ofcollagen, each called an annulus, which forms a part of the fibrousskeleton of the heart. The annulus provides peripheral attachments forthe two cusps or leaflets of the mitral valve (called the anterior andposterior cusps) and the three cusps or leaflets of the tricuspid valve.The free edges of the leaflets connect to chordae tendinae from morethan one papillary muscle. In a healthy heart, these muscles and theirtendinous chords support the mitral and tricuspid valves, allowing theleaflets to resist the high pressure developed during contractions(pumping) of the left and right ventricles.

Although valve regurgitation often occurs due to the dilatation of thevalve annulus, mitral and tricuspid valve function and competencyfrequently depend on the fine geometric and functional integrity of thevalve's supporting structures, such as, for example, the associatedsubvalvular apparatus. The subvalvular apparatus of these heart valvesinclude, among other things, the associated chordae tendinae andpapillary muscles.

As seen in FIGS. 1 and 2, the mitral valve (MV) is a two-leaflet (orbicuspid) structure of connective tissue separating the left atrium (LA)from the left ventricle (LV). The mitral valve functions to maintainblood flow in one direction, i.e., from the left atrium toward the leftventricle during ventricular relaxation or diastole, while preventingback flow in the opposite direction during ventricular contraction orsystole. The anterior leaflet (AL) and posterior leaflet (PL) areseparated by the anterior commissure (AC) and posterior commissure (PC).The bases of the two valve leaflets are attached to a circular fibrousstructure of the heart called the mitral annulus (AN), and the leafletfree edges are attached to chordae tendinae arising from the papillarymuscles of the left ventricle. An anterior leaflet (AL) is relativelylarge and attaches to the anterior segment of the annulus, while aposterior leaflet (PL) is smaller but extends further circumferentiallyand attaches to the posterior segment of the annulus. The posteriorleaflet presents three scallops identified as P1, P2, P3, while thecorresponding non-scalloped parts of the anterior leaflet are identifiedas A1, A2, and A3, according to Carpentier's segmentation.

The tricuspid valve also has subvalvular structures, but is a tricuspid(i.e., three cusp or leaflet) structure as opposed to the bicuspidstructure of the mitral valve. Some mitral and tricuspid valvereplacement procedures involve the removal of these subvalvularstructures. However, the subvalvular structures may play a role inmaintaining the proper shape of the ventricles, and thus theirpreservation may be desirable, depending on the particularcircumstances.

When the left ventricle contracts after filling with blood from the leftatrium, the walls of the ventricle move inward and release some of thetension from the papillary muscle and chords. The blood pushed upagainst the under-surface of the mitral leaflets causes them to risetoward the annulus plane of the mitral valve. As they progress towardthe annulus, the leading edges of the anterior and posterior leafletcome together forming a seal and closing the valve. In the healthyheart, leaflet coaptation occurs near the plane of the mitral annulus.The blood continues to be pressurized in the left ventricle until it isejected into the aorta. Contraction of the papillary muscles issimultaneous with the contraction of the ventricle and serves to keephealthy valve leaflets tightly shut at peak contraction pressuresexerted by the ventricle.

The native heart valves (such as the aortic, pulmonary, tricuspid, andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be rendered less effective by congenital, inflammatory,infectious conditions, or other disease. Such damage to the valves canresult in serious cardiovascular compromise. Heart valve disease is awidespread condition in which one or more of the valves of the heartfails to function properly. Diseased heart valves may be categorized aseither stenotic, wherein the valve does not open sufficiently to allowadequate forward flow of blood through the valve, and/or incompetent,wherein the valve does not close completely, causing excessive backwardflow of blood or regurgitation through the valve when the leaflets aresupposed to coapt together to prevent regurgitation. Valve disease canbe severely debilitating and even fatal if left untreated. For manyyears the definitive treatment for such disorders was the surgicalrepair or replacement of the valve during, for example, open heartsurgery.

Various surgical techniques may be used to repair a diseased or damagedvalve, which is typically used on minimally calcified valves. Surgicalrepair of the native valve is commonly conducted using so-calledannuloplasty rings. Examples of annuloplasty rings, including methods ofuse for repairing native valves, are disclosed in U.S. Pat. No.4,055,861, filed Apr. 9, 1976 and entitled “Support for a Natural HeartValve”; U.S. Pat. No. 5,041,130, filed Nov. 30, 1989 and entitled“Flexible Annuloplasty Ring and Holder”; U.S. Pat. No. 6,558,416, filedMar. 6, 2001 and entitled “Annuloplasty Ring Delivery Method”; and inco-pending U.S. patent application Ser. No. 13/019,506, filed Feb. 2,2011 and entitled “Devices and Methods for Treating a Heart,” the entirecontents of each of which are incorporated herein by reference.

Sometimes actual replacement of the heart valve is the preferred option.Heart valve replacement may be indicated when there is a narrowing of anative heart valve, commonly referred to as stenosis, or when the nativevalve leaks or regurgitates, such as when the leaflets are calcified.Due to aortic stenosis and other heart valve diseases, thousands ofpatients undergo surgery each year wherein the defective native heartvalve is replaced by a prosthetic valve, either bioprosthetic ormechanical. Prosthetic cardiac valves have been used for many years totreat cardiac valvular disorders.

When the valve is replaced, surgical implantation of the prostheticvalve typically requires an open-chest surgery during which the heart isstopped and patient placed on cardiopulmonary bypass (a so-called“heart-lung machine”). In one common surgical procedure, the diseasednative valve leaflets are excised and a prosthetic valve is sutured tothe surrounding tissue at the valve annulus. Because of the traumaassociated with the procedure and the attendant duration ofextracorporeal blood circulation, some patients do not survive thesurgical procedure or die shortly thereafter. It is well known that therisk to the patient increases with the amount of time required onextracorporeal circulation. Due to these risks, a substantial number ofpatients with defective valves are deemed inoperable because theircondition is too frail to withstand the procedure. By some estimates,about 30 to 50% of the subjects suffering from aortic stenosis who areolder than 80 years cannot be operated on for aortic valve replacement.

Because of the drawbacks associated with conventional open-heartsurgery, percutaneous and minimally-invasive surgical approaches aregarnering intense attention. In one technique, a prosthetic valve isconfigured to be implanted in a much less invasive procedure by way ofcatheterization. For instance, U.S. Pat. No. 5,411,552 to Andersen etal. describes a collapsible valve percutaneously introduced in acompressed state through a catheter and expanded in the desired positionby balloon inflation. Although these remote implantation techniques haveshown great promise for treating certain patients, replacing a valve viasurgical intervention is still the preferred treatment procedure. Onehurdle to the acceptance of remote implantation is resistance fromdoctors who are understandably anxious about converting from aneffective, if imperfect, regimen to a novel approach that promises greatoutcomes but is relatively foreign. In conjunction with theunderstandable caution exercised by surgeons in switching to newtechniques of heart valve replacement, regulatory bodies around theworld are moving slowly as well. Numerous successful clinical trials andfollow-up studies are in process, but much more experience with thesenew technologies will be required before they are completely accepted.

In some situations, replacement of the native heart valve with aprosthetic heart valve may be the desired treatment. There areapproximately 60,000 mitral valve replacements (MVR) each year and it isestimated that another 60,000 patients should receive a MVR due toincreased risk of operation and age. The large majority of thesereplacements are accomplished through open-heart surgery, where aprosthetic heart valve is surgically implanted with the patient onpulmonary bypass. Such surgically implanted prosthetic valves have along and proven record, with high success rates and clinicalimprovements noted after such valve replacement. However, it can bedesirable to keep the time that the patient spends on pulmonary bypassto a minimum.

Surgeons relate that one of the most difficult tasks when attemptingvalve repair or replacement, either in open heart surgeries or minimallyinvasive heart valve implantations (e.g., through small incisions) istying the suture knots that hold the valve or repair ring in position. Atypical prosthetic mitral valve implant utilizes 12-24 sutures (commonlyabout 15) distributed evenly around and manually tied on one side of thesewing ring. The implantation process can be very time consuming anddifficult to perform, particularly through minimal size incisions due tothe numerous pairs of sutures that need to be precisely placed in theannulus and the knots that are typically used to secure the sutures whenthe valve is parachuted into place. Similarly, in a valve repairprocedure numerous pairs of sutures must be precisely placed around thenative annulus to attach the repair device. Minimizing or eveneliminating the need to use suture (and/or to tie suture knots) forattachment of prosthetic valves or repair devices would greatly decreasethe time of the procedure and/or facilitate the use of smallerincisions, thus reducing infection risk, reducing the need for bloodtransfusions, reducing the time spent on bypass, and allowing more rapidrecovery.

Accordingly, there is a need for an improved device and associatedmethod of use wherein a prosthetic valve or valve repair device can beimplanted in a more efficient procedure that reduces the time requiredon extracorporeal circulation and/or catheterization. It is desirablethat such a device and method be capable of helping patients withdefective valves that are deemed inoperable because their condition istoo frail to withstand a lengthy conventional surgical procedure. Thepresent invention addresses these needs and others.

SUMMARY OF THE INVENTION

A valve repair or replacement device for implantation at a native valveannulus and method of implanting the same is disclosed. The device maybe a prosthetic valve, annuloplasty ring, or other device forimplantation at the native valve annulus. The device has a centralportion with one or more anchors extending therefrom from fixed endssecured to the central portion, with the anchors terminating at freeends. The anchors run substantially parallel to the circumference of thecentral portion in a curved fashion, forming leaflet-receiving slotsbetween the anchors and central portion. The device is configured to bepositioned at the native valve annulus, and then rotated (twisted) toplace the anchors underneath the resident valve leaflets, with theresident valve leaflets sliding into the leaflet-receiving slots untilthe device is fully seated. The leaflets are then held within the slots,which may include inward pressure from the anchor arms that press theleaflets between the anchor arms and the central portion of the device.

The anchors may extend from the central portion, and may include across-section configured to have a different stiffness in-plane than thestiffness out-of-plane. There may be one, two, three, four, or moreanchors extending from the central portion. The anchors may extend fromthe central portion at different positions around the circumferencethereof, and may be generally equidistantly positioned around thecircumference. The anchors may be formed of metal or polymer or othersuitable material, and the device may include a cloth covering. Thedevice may include radiopaque markers and other structures to enhancevisibility during implantation. For example, an anchor member may haveone or more radiopaque markers positioned thereon, such as at the tip ofthe free end and/or at the fixed end.

The assembly may form a prosthetic valve formed by support frame andvalve leaflets, with the support frame having a central portion and oneor more curved anchors extending therefrom to form at least one slotbetween the anchor(s) and central portion, with the at least one slotsized to slidingly receive a proximal portion of a heart valve leaflettherein. The anchors and slots may be preferably sized and configured toengage resident leaflets. For example, at least one slot may have awidth of similar size to the thickness of a native valve leaflet.

A device for treating a heart according to an embodiment of theinvention comprises a prosthetic valve having a support frame and avalve portion. The valve portion may include a plurality of leafletssecured to the support frame and configured to coapt to permit bloodflow in a first direction through the valve portion and to prevent bloodflow in a second direction through the valve portion, wherein the firstdirection is opposite to the second direction, wherein the support framecomprises one or more attachment structures configured to be attached,and/or to otherwise facilitate attachment of the device, to tissue at oradjacent an annulus of a native heart valve.

The prosthetic valve may be configured for surgical implantation, eithervia traditional open-heart or minimally invasive techniques, and/or viacatheterization. The support frame may have supplemental attachmentstructures (i.e., in addition to the anchors) for securing theprosthetic valve at a desired location at a native heart valve annulus.For example, the support frame may comprise a sewing ring configured tobe sutured to tissue of the annulus of the native heart valve, and/ormay include other attachment structures configured to secure the supportframe at the valve annulus using no (or minimal) suture, such as anexpandable stent structure, clamps, skirts, or other elements configuredto engage tissue of, or adjacent to, the native annulus in order tosecure the prosthetic valve at the desired position. Examples ofsutureless securement devices and methods for use with the currentinvention are disclosed in U.S. patent application Ser. No. 12/821,628,filed Jun. 23, 2010 and entitled “Unitary Quick-Connect Prosthetic HeartValve and Deployment System and Methods,” and also in U.S. patentapplication Ser. No. 13/167,639, filed Jun. 23, 2011 and entitled“Systems and Methods for Rapidly Deploying Surgical Heart Valves,” theentire contents of each of which are expressly incorporated herein byreference.

An embodiment of the invention is a prosthetic heart valve assembly forreplacing a resident heart valve, comprising a prosthetic valve andanchors extending therefrom. The prosthetic valve may have a supportframe and a valve portion. The valve portion is a one-way valve, whichmay have a plurality of leaflets secured to the support frame about acentral axis of the prosthetic valve to an internal flow lumen andconfigured to coapt to permit blood flow in a first direction throughthe internal flow lumen and to prevent blood flow in a second directionthrough the internal flow lumen. The prosthetic valve has an exteriorsurface, which may be configured to engage tissue of a heart. At leastone anchor member extends from the support frame, the anchor membercomprising a proximal fixed end secured to the support frame and adistal free end. The anchor member extends at least partially around thecircumference of the prosthetic valve (radially about the central axisthereof) and substantially parallel to the prosthetic valve exterior todefine a leaflet-receiving slot configured to slidingly receive aleaflet of a heart valve. The leaflet-receiving slot extends incontinuous, unbroken fashion from the proximal fixed end of the anchormember to the distal free end of the anchor member. The slot is sizedand configured to slidingly receive and hold a desired valve leaflet ofa resident valve, where a resident valve is a native heart valve or apreviously-implanted prosthetic valve. Depending on the particularapplication, the slot may have a length of 0.25 to 3.5 inches and awidth of 0.005 to 0.25 inches.

The prosthetic valve may be substantially tubular, with the exteriorsurface forming a substantially continuously curved surface about thecircumference thereof, with the anchor member forming a curve whichparallels the curved surface of the exterior surface of the valve.

A valve assembly according to the invention may form a prosthetic mitralvalve assembly with first and second anchor members defining first andsecond leaflet-receiving slots and having first and second fixed endsand first and second free ends, respectively. Each slot extends incontinuous, unbroken fashion from the anchor fixed end to the anchorfree end. The anchors can be sized and positioned to engage the anteriorand posterior leaflets of a native mitral valve, so that the slots aresized to receive these leaflets. The first and second anchors may havefixed ends which are spaced at least 90 degrees apart, and morespecifically about 100 to 140 degrees apart, and more specifically 120degrees apart, about the circumference of the device, with the anchorextending in the same rotational direction (e.g., clockwise) about thecircumference of the device. The first anchor member may pass around thecircumference of the prosthetic valve through an angle of at least 90degrees, with the second anchor passing around the circumference of theprosthetic valve through an angle of at least 120 degrees.

An assembly according to the invention may form an annuloplasty ringhaving a support ring having a circumference and comprising a centralopening defining a flow axis through which fluid may flow, a coveringaround the support ring, the covering comprising an outer surface, and afirst anchor member extending from the support frame. The first anchormay have a first proximal fixed end secured to the support ring and afirst distal free end, wherein the first anchor member extends around atleast partially around a circumference of the support ring andsubstantially parallel to outer surface of the covering to define afirst leaflet-receiving slot configured to receive a leaflet of a heartvalve. The first leaflet-receiving slot may preferably extend incontinuous, unbroken fashion from the first proximal fixed end to thefirst distal free end. The first anchor member may extend around thecircumference of the prosthetic valve through an angle of at least 90degrees.

An annuloplasty ring may further include additional anchor members. Forexample, it may include a second anchor member having a second proximalfixed end secured to the support ring and a second distal free end,wherein the second anchor member extends at least partially around thecircumference of the annuloplasty ring and substantially parallel to theexterior thereof to define a second leaflet-receiving slot configured toreceive a second leaflet of a heart valve. The second leaflet-receivingslot may extend in continuous, unbroken fashion from the second proximalfixed end to the second distal free end. The second proximal fixed endmay be circumferentially displaced from the first anchor proximal fixedend by an angle of at least 90 degrees, by an angle of between 100 and140 degrees, or by an angle of about 120 degrees. The first anchor mayextends around the circumference of the annuloplasty ring through anangle of between 90 and 120 degrees, and the second anchor may extendaround the circumference of the annuloplasty ring through an angle ofbetween 150 and 240 degrees. The support ring may be substantiallycircular, substantially D-shaped, and/or substantially saddle-shaped.

Methods of implanting a device (e.g., annuloplasty ring, prostheticvalve, etc.) at a native valve annulus can include providing a devicecomprising a central portion, a first curved anchor extending from afirst fixed end secured to the central portion and passing generallyparallel to an outer surface thereof to a first free end of the firstcurved anchor to form a first leaflet-receiving slot, a second curvedanchor extending from a second fixed end secured to the central portionand passing generally parallel to an outer surface thereof to a secondfree end to form a second leaflet-receiving slot, wherein the centralportion defines a flow orifice with a flow axis therethrough. The methodmay include positioning the device with the first curved anchor andsecond curved anchor adjacent the native valve annulus, with the fluidflow axis of the device generally parallel to a fluid flow path throughthe native valve annulus, and with the first free end positionedadjacent a first commissure of a resident valve at the native valveannulus; placing the first free end underneath a first resident valveleaflet; rotating the device substantially about the fluid flow axisthereof to advance the first free end underneath the first residentvalve leaflet and thereby slidingly advancing the first resident valveleaflet into the first leaflet-receiving slot; monitoring the positionof the second free end with respect to a second commissure of theresident valve; and stopping rotation of the device about the fluid flowaxis once the second free end is adjacent the second commissure of theresident valve. Once the second free end is adjacent the secondcommissure, the surgeon or other user can place the second free endunderneath a second resident valve leaflet; recommencing rotating thedevice substantially about the fluid flow axis thereof to advance thesecond free end underneath the second resident valve leaflet and therebyslidingly advancing the second resident valve leaflet into the secondleaflet-receiving slot while also further advancing the first free endunderneath the first resident valve leaflet and further slidinglyadvancing the first resident valve leaflet into the firstleaflet-receiving slot; and stop rotation of the device when the firstresident valve leaflet is slidingly advanced into the firstleaflet-receiving slot at a position adjacent the first fixed end,whereby deployment of the device is completed.

The native valve annulus may be a mitral valve annulus or a tricuspidvalve annulus. If the native annulus is a tricuspid annulus, the devicemay include three anchors spaced around the perimeter of the device,with each anchor configured to slidingly receive one of the three valveleaflets of the resident tricuspid valve. Where the native valve annulusis a mitral valve annulus with intact native mitral valve leaflets, thefirst commissure may be a PC commissure of a native mitral valve, thefirst leaflet may be an anterior leaflet of the native mitral valve, thesecond commissure may be an AC commissure of the native mitral valve,and the second leaflet may be a posterior leaflet of the native mitralvalve.

Methods of implanting the device include open heart surgery, includingsurgery where prior to positioning the device adjacent the native valveannulus, the surgeon or other user temporarily ceases heart function ofthe heart and places the patient on cardiopulmonary bypass. Aftercompleting deployment of the device, the heart function of the heart maybe resumed and the patient then removed from cardiopulmonary bypass.

Methods of the invention include providing a valve repair or replacementdevice. The device may comprise an annuloplasty ring with one or moreanchors extending therefrom, or may comprise a prosthetic valve with asupport frame and leaflets with the leaflets secured to the supportframe to form a one-way valve structure and with one or more anchorsextending from the support frame. Each anchor has a proximal end securedto the support frame and a free distal end, with a slot defined betweenthe support frame and the anchor. The anchor is positioned adjacent acommissure point of the native valve, and the free end is positionedunderneath a native leaflet of the valve (and below the native heartvalve annulus). The device (e.g., annuloplasty ring or prosthetic heartvalve) is rotated about its central axis to advance the anchorunderneath the native leaflet, so that the native leaflet is slidinglyadvanced into the slot. Advancement and securement can be performed inan open-heart or minimally-invasive procedure. The central portion(e.g., ring portion or support frame) may comprise a sewing ring, andsecuring the support frame to the tissue of the native heart valveannulus may include suturing the sewing ring to tissue of the nativeheart valve annulus. The device may comprise a stent, with the stentbeing expanded into contact with native tissue before, during, or afterthe anchor(s) are rotated underneath the resident leaflets). The nativevalve annulus may be of any heart valve, with particular application tomitral and tricuspid valves.

After the central portion is secured to the native valve annulus, thesurgeon or other user may add one or more stitches or other securingdevice/methods to secure the device to the local tissue in order toprevent the device from rotating back out of its deployed position. Insuch a deployment, the anchors hold the device to prevent movement up,down, sideways, etc., while the sutures or other tissue connectors serveto prevent the device from rotating such that the leaflets rotatinglyslide out of the slots to be released from the anchors.

The method may include temporarily ceasing heart function of the heartand placing the patient on cardiopulmonary bypass, performing varioussteps (such as advancement and securing of the prosthetic valve to thenative annulus), and then resuming heart function of the heart andremoving the patient from cardiopulmonary bypass. Deployment of thedevice may occur with the patient on bypass, or may occur with thepatient's heart beating (e.g., after the patient is removed from bypass,with heart function restarted) and with the surgeon or other usermonitoring the heart function and/or ventricular shape as the lengthadjustments are made.

Methods of the invention may include, prior to securing the supportframe to the tissue of the native heart valve annulus, removing somenative valve leaflets and/or subvalvular structure (e.g., chordaetendinae) from the heart.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of the left side of the human heartshowing the left atrium separated from the left ventricle by the mitralvalve;

FIG. 2 is a surgeon's or plan view of a mitral valve in the closedposition illustrating the anterior leaflet (AL) and the posteriorleaflet (PL) attached to the annulus (AN), and indicating identifiableleaflet segments;

FIG. 3 is a bottom view of an embodiment of a device according to anembodiment of the invention;

FIGS. 4 and 5 are perspective (in partial cross-section) and top viewsof an embodiment of a device deployed in a heart according to anembodiment of the invention;

FIGS. 6A-6C are top views of a device being deployed in a mitral valveannulus according to the invention;

FIGS. 7A-7D are side, bottom, perspective, and top views, respectivelyof a prosthetic heart valve according to an embodiment of the invention;

FIGS. 8A and 8B are side views of a device according to an embodiment ofthe invention;

FIGS. 9A and 9B are perspective and close-up cross-sectional views of adevice according to an embodiment of the invention;

FIG. 10 is a perspective view of a device according to an embodiment ofthe invention;

FIG. 11 is a top view of a device according to an embodiment of theinvention;

FIG. 12 is a top view of a device according to an embodiment of theinvention;

FIG. 13 is a perspective view of a device according to an embodiment ofthe invention;

FIGS. 14A-14B are perspective views of devices according to embodimentsof the invention; and

FIG. 15 is a top view of a device according to an embodiment of theinvention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention is an anchoring device, including prosthetic heart valvesand annuloplasty rings and other devices using that anchoring device,for securement within a patient, such as in a native heart valve annulusin a human heart. The device has particular applicability to devices tobe secured at the annulus of a valve (such as the mitral and tricuspidvalves) which has subvalvular structures such as chordae tendinae. Amitral valve and its subvalvular structure are depicted in FIGS. 1 and2.

FIG. 3 depicts a device 10 for anchoring a prosthetic heart valve orrepair ring to the mitral annulus of a heart. The device 10 may be madeof a metal such as stainless steel, although other materials (metal ornon-metal) may be suitable. The device 10 is composed of a central ring12 having two semi-circular anchors, namely an anterior anchor 14 a anda posterior anchor 14 p, attached to and extending from the central ring12 at positions spaced apart around the circumference of the ring by anangle 16 of approximately 120 degrees. This angle and spacing dividesthe device 10 into approximately ⅓ and ⅔ sections, thus approximatingthe proportions of the anterior leaflet and posterior leaflet of anative mitral valve. The anchors 14 a, 14 p are spaced slightly awayfrom and run substantially parallel to the outer circumference of thecentral ring 12, and define an anterior leaflet receiving slot 18 a andposterior leaflet receiving slot 18 p, respectively. The leafletreceiving slots 18 a, 18 p have a width 20 a, 20 p which is generally onthe order of the thickness of the anterior and posterior leaflets of amitral valve, i.e., the slots 18 a, 18 p have a width of about 0.005 to0.25 inches. These slot widths 20 a, 20 p are sufficient to permit theanterior and posterior leaflets of a mitral valve to slidingly enter theslots 18 a, 18 p. The slots 18 a, 18 p have lengths 22 a, 22 psufficient to receive a substantial portion of the respective mitralvalve leaflets. The length 22 a of the anterior leaflet receiving slot18 a may be between about 0.25 to 3.5 inches, while the length 22 p ofthe posterior leaflet receiving slot 18 p may be between about 0.25 and3.5 inches. The central ring 12 defines an inner opening 24 having aninner diameter 26. If the device 10 is part of a prosthetic heart valve(e.g., part of a support stent of a prosthetic heart valve), the innerdiameter 20 may be between 0.75 to 1.5 inches. If the device 10 is partof a valve repair device such as an annuloplasty ring, the innerdiameter may be between 0.75 to 1.5 inches.

FIGS. 4 and 5 depict the device 10 anchored in a mitral valve annulusAN. The anterior leaflet AL is positioned within the anterior leafletslot 18 a such that the slot 18 a holds a proximal portion of theanterior leaflet AL (with the proximal portion of the leaflet beingadjacent the annulus AN, as opposed to a distal portion which isadjacent the leaflet edge). Similarly, the posterior leaflet PL ispositioned within the posterior leaflet slot 18 p such that the slot 18p receives a proximal portion of the posterior leaflet PL (with theproximal portion of the leaflet being adjacent the annulus AN, asopposed to a distal portion which is adjacent the leaflet edge). Theanterior and posterior anchors 14 a,14 p are thus positioned betweentheir respective leaflets AL, PL and the ventricle wall, while thecentral ring 12 is positioned within the mitral valve annulus AN. Theanchors 14 a, 14 p and slots 18 a, 18 p thus prevent migration of thedevice, e.g., into the atrium during systole or into the ventricleduring diastole. The leaflet slots 18 a, 18 p serve to grip the leafletsAL, PL to anchor the device 10 in the desired position in the annulusAN.

FIGS. 6A-6C depict schematically the installation of the device 10, asviewed from the left atrium (i.e., looking through the mitral valve intothe left ventricle). In FIG. 6A, the device 10 is positioned with thecentral ring 12 generally centrally positioned in the mitral valveannulus AN, and with the posterior anchor free end 28 p adjacent the ACcommissure. The posterior anchor free end 28 p is inserted (e.g., bymanipulating the device 10 as a whole and/or by bending the posterioranchor free end 28 p away/downward from its normal position adjacent thecentral ring 12) between the anterior and posterior leaflets so it ispositioned underneath the posterior leaflet PL, and the device 10 isthen rotated counter-clockwise, with the posterior leaflet PL slidinginto the posterior anchor slot 18 p, to the point where the anterioranchor free end 28 a is adjacent the PC commissure, as depicted in FIG.6B. The anterior anchor free end 28 a is then inserted (e.g., bymanipulating the device 10 as a whole and/or by bending the anterioranchor free end 28 a away/downward from its normal position adjacent thecentral ring 12) between the anterior and posterior leaflets so it ispositioned underneath the anterior leaflet AL, and the device 10 isfurther rotated clockwise with the anterior leaflet AL sliding into theanterior anchor slot 18 a (and the posterior leaflet PL further slidinginto the posterior anchor slot 18 b) until the device is fully seated.When fully seated, as depicted in FIG. 6C, both anchors 14 a, 14 p arebeneath their respective leaflets AL, PL, the attachment bar 30 a of theanterior leaflet anchor 14 a is positioned at the PC commissure, and theattachment bar 30 p of the posterior leaflet anchor 14 p is positionedat the AC commissure.

FIGS. 7A-7D depict a prosthetic mitral valve assembly 40 utilizing ananchoring assembly of the invention. The valve assembly 40 has atri-leaflet valve portion 42 secured to a support structure 44. Thesupport structure 44 includes an anchoring device 46, which itself has acentral ring 48 with posterior and anterior anchors 50 a, 50 p definingposterior and anterior slots 52 a, 52 p configured to slidingly receiveposterior and anterior leaflets of a mitral valve. The assembly 40further includes an upstream stent structure 54 which is configured tobe expanded into engagement with surrounding tissue, such as with theatrium wall. The stent could be either self-expanding or balloonexpandable. The stent 54 would preferably be crimped (in the case ofballoon expandable) or restrained (in the case of self-expandable), to arelatively small delivery diameter, as depicted in FIG. 8A, fordelivery. Once the anchor portion was fully engaged with the nativevalve leaflets (i.e., rotated into engagement), the stent could bedeployed to its expanded condition, as depicted in FIG. 8B. If the stentportion 54 were self-expanding, the delivery catheter would need asheath to restrain the stent in its compressed delivery configuration.If the stent were balloon expandable, the delivery catheter would need aballoon or similar radially expansion device to radially expand thestent.

The configurations of various elements could vary at different positionson the assembly. For example, the cross-sectional shape of the anchorsand/or central ring could be other than rectangular, and/or could varyalong their lengths. For example, as depicted in FIGS. 9A and 9B, ananchor assembly 60 could have a central ring 62, with anchor portions 64a, 64 p having a “C”-shaped channel cross section. The cross sectionshape could be designed such that the in-plane stiffness of the anchorswas substantially less than their out-of-plane stiffness, or vice-versa.Such differential stiffness could help the anchors conform to the nativeannulus during insertion while still providing high retention forces inthe axial direction.

FIG. 10 depicts a further embodiment of the device, wherein an anchorassembly 70 has a posterior anchor 72 p and an anterior anchor 72 a, butthe anchors 72 a, 72 p are secured to separate assembly ring portions 74a, 74 p. These separate ring portions 74 a, 74 p can rotate with respectto each other, thereby permitting separate (independent) rotation of theanchors 72 a, 72 p with respect to each other. Such independent rotationof the anchors 72 a, 72 p could make installation of the device easierfor the surgeon or other user.

Various modifications could be made to promote ease of use. For example,an anchor device 80 portion could have a central ring 82 and anchors 84a, 84 p having rounded or otherwise blunted ends, such as thespherical-tipped ends 86 a, 86 p depicted in FIG. 11, to reduce thepotential for the tips to snag on or traumatize the tissue of theleaflets, ventricle wall, chordae, etc., as the leaflets are slid intothe slots 88 a, 88 p. Such structures could make it easier for theanchors 84 a, 84 p to be threaded behind the valve leaflets. The roundedstructures could be formed as a unitary portion (i.e., at the same time,of the same material, etc.) with the anchors, or could be separatepieces attached to the anchors during manufacture. For example, therounded portions could be formed from PTFE which is press-fit and/orglued to the anchors.

An anchoring device according to the invention could use variousmaterials, and could include coverings, etc. For example, the structureof the anchoring device (formed of, e.g., metal) could include a clothcovering. Such coverings could serve multiple purposes. For example,covering the device with a biocompatible covering which encouragestissue ingrowth, such as PTFE cloth, would encourage the patient'snative tissue to attach to the device over time, possibly reducingtissue irritation and potential damage from metal-on-tissue contact. Thetissue ingrowth could also assist to improve the anchoring of thedevice, by providing mechanical stability and thereby reduce the chanceof migration and embolization. The covering, especially a clothcovering, could also provide the ability for a surgeon or other user touse sutures to further secure the device in place. A flexible/resilientcovering, such as cloth, could also provide a surface which would “giveway” (e.g., be compressed) to permit the leaflets to be slid into theslots, but would also push back (i.e., rebound) into the slots to engagethe leaflets once in place and assist in holding the device in place. Acovering could also be used to hold a lubricious coating, such asglycerol, which could facilitate the threading of the anchors betweenthe leaflets and the ventricle.

Coverings, if present, could be configured to bioresorb or otherwisedegrade over time, or could be formed from material(s) that will notbiodegrade/bioresorb over time. Examples of such materials for potentialuse with the invention include PTFEs, polyesters, nylons, and others.

The structural support portions of devices according to the inventioncould be formed from metals or non-metals, including stainless steel,nitinol, titanium, CoCr, alloys, polymeric materials, and otherbiocompatible materials. The structural support portions (i.e., thecentral ring and anchors) may preferably be formed from materials whichare substantially rigid with minimal elasticity, and which are noteasily plastically deformed. Devices according to the invention mayinclude radiopaque markers and other structures to enhance visibilityduring implantation. For example, an anchor member may have one or moreradiopaque markers positioned thereon, such as at the tip of the freeend and/or at the fixed end. Such radiopaque markers may be formed fromhighly-radiopaque materials (e.g., gold, platinum) mounted on, embeddedin, formed with, or otherwise secured to the structural support and/orother portions of the device.

FIG. 12 depicts a further embodiment of an anchor assembly 90, where acentral ring 92 has three anchors 94 a, 94 b, 94 c positioned around theperimeter of the device. In the specific embodiment depicted, theanchors 94 a, 94 b, 94 c are spaced at about 120 degrees to each other,although other spacings are within the scope of the invention. Thethree-anchor design could be applicable for deployment at non-mitralvalve locations, such as at the tricuspid valve position (i.e., thevalve and annulus between the right ventricle and right atrium).Alternatively, such an assembly could be used for anchoring at themitral valve, where one of the arms (e.g., arm 94 a) was used to besecured to the anterior leaflet, and the other two arms (e.g., arms 94a, 94 c) were used to be secured to the posterior leaflet. In order toproperly thread the device into place, the surgeon or other user mightneed to form an incision in the posterior leaflet, such as at theposition midway between the commissure points AC and PC near theleaflet/annulus junction, in order to advance the “extra” arm (i.e., arm94 c) underneath the posterior leaflet. The posterior leaflet would thenhave two anchors—one starting at the AC commissure and one starting atthe middle of the posterior leaflet (i.e., in the so-called “P2”section). Such a configuration may provide improved deployment andanchoring capabilities.

A further embodiment of the invention is depicted in FIG. 13, wherein ananchor assembly 100 has a central portion 102 with anchors 104 a,104 ppositioned below (e.g., downstream of) the central portion 102. Thisconfiguration provides the potential for having a larger central opening106 on the central portion 102 for a given native valve annulus size,which could thus accommodate a larger prosthetic valve orifice (wherethe anchor assembly is part of a prosthetic valve assembly) or a largernative valve orifice (where the anchor assembly is part of a repairdevice such as an annuloplasty ring).

FIGS. 14A and 14B depict further embodiments of an anchor assembly 110,wherein anchors 112 a, 112 p are secured directly to a central portionin the form of a stent structure 114. The stent structure 114 is thusthe central portion in lieu of a central ring portion such as depictedin FIG. 3. FIG. 14B has the addition of the valve support assembly(i.e., commissure supports 116) being formed with or otherwise attachedto the assembly 110. Such anchor assemblies could be useful as part of aprosthetic valve assembly, such as that previously depicted in FIGS.7A-7D. The embodiments of FIGS. 14A-14B have the additional advantagethat the entire anchor assembly can be radially compressed, so that aprosthesis (e.g., annuloplasty ring and/or prosthetic heart valve) couldbe crimped or otherwise radially compressed into a smaller deliveryprofile for potential delivery to and deployment at the native annulusvia catheterization (e.g., percutaneous/MIS). The device as shown inFIGS. 14A-14B could be delivered through a catheter in a percutaneous orminimally-invasive type intervention, or via open heart.

Although the embodiments depicted above generally had substantiallycircular configurations, which may be preferred in some applicationssuch as prosthetic heart valves and annuloplasty rings, the invention isnot so limited. For example, non-circular configurations could also beused, such as the generally D-shaped configuration depicted in FIG. 15.The anchor assembly 120 has a central portion 122 which is substantiallyD-shaped, with anchors 124 a, 124 p extending therefrom and curving tomatch the substantially D-shape of the central portion 122. Suchnon-circular configurations could be particularly useful where theanchor assembly 120 was serving as part of an annuloplasty ring orsimilar repair device, such as an annuloplasty ring for the mitralvalve. Note that an anchor assembly according to the invention, whethercircular or non-circular, does not have to be planar. For example,three-dimensional forms, such as a so-called “3D saddle shape” like thatdisclosed in U.S. Pat. No. 6,805,710, issued Oct. 19, 2004 and entitled“Mitral Valve Annuloplasty Ring for Molding Left Ventricle Geometry”(the entire contents of which are incorporated by reference herein)could also be used with the invention in order to form a device toconform to, or to deform/reshape, the native anatomy.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims.

What is claimed is:
 1. A method of implanting a prosthetic implant at anative valve annulus having resident valve leaflets, comprising:providing a prosthetic implant comprising an anchoring device having tworing portions each having an associated anchor extending therefrom, thering portions each being rotatable with respect to each other, each ofthe anchors having a proximal fixed end secured to the associated ringportion and terminating in a distal free end not connected to theassociated ring portion, wherein each of the anchors is spaced slightlyaway from and runs in a continuous, unbroken fashion substantiallyparallel to a circumference of the associated ring portion so as to forma valve leaflet-receiving slot between the anchor and the associatedring portion; positioning the anchoring device with the anchors adjacentthe native valve annulus, with a fluid flow axis of the prostheticimplant generally parallel to a fluid flow path through the native valveannulus; and independently rotating each of the ring portions to advancethe distal free ends of each anchor underneath a resident valve leafletthereby slidingly advancing the resident valve leaflets into theleaflet-receiving slots.
 2. The method of claim 1, wherein theprosthetic implant comprises a prosthetic heart valve having a supportframe and leaflets with the leaflets secured to the support frame toform a one-way valve structure controlling fluid flow along the flowaxis, and, wherein the anchoring device is secured to the support frame.3. The method of claim 1, wherein each anchor lies in the same plane asand radially outward from the associated ring portion.
 4. The method ofclaim 1, wherein each anchor lies in a different plane than and axiallyspaced from the associated ring portion.
 5. The method of claim 1,wherein in an anchored configuration the proximal fixed ends of theanchors are spaced at least about 120 degrees apart.
 6. The method ofclaim 1, wherein the device has two anchors, one on each ring portion,and one of which is longer than the other.
 7. The method of claim 1,further comprising a cloth covering around each of the anchors.
 8. Amethod, comprising: providing an anchoring device having two ringportions each having an associated anchor extending therefrom, the ringportions each being rotatable with respect to each other, each of theanchors having a proximal fixed end secured to the associated ringportion and terminating in a distal free end not connected to theassociated ring portion, wherein each of the anchors runs along acircumference of the associated ring portion so as to form a valveleaflet-receiving area between the anchor and the associated ringportion; positioning the anchoring device with the anchors proximate anative valve annulus; and rotating one of the two ring portions toslidingly advance a native valve leaflet into the leaflet-receiving areaassociated therewith.
 9. The method of claim 8, further comprisingindependently rotating another of the two ring portions to slidinglyadvance another native valve leaflet into the leaflet-receiving areaassociated therewith.
 10. The method of claim 8, wherein the anchoringdevice has a prosthetic heart valve secured therein, the prostheticheart valve having a support frame and leaflets with the leafletssecured to the support frame to form a one-way valve structurecontrolling fluid flow along the flow axis.
 11. The method of claim 8,wherein each anchor lies in the same plane as and radially outward fromthe associated ring portion.
 12. The method of claim 8, wherein eachanchor lies in a different plane than and axially spaced from theassociated ring portion.
 13. The method of claim 8, wherein the devicehas two anchors, one on each ring portion, and one of which is longerthan the other.
 14. The method of claim 8, further comprising a clothcovering around each of the anchors.
 15. A method, comprising: providingan anchoring device having a first ring portion having a first anchorextending therefrom and a second ring portion having a second anchorextending therefrom, the first ring portion being rotatable relative tothe second ring portion, wherein the first anchor has a first fixed endsecured to the first ring portion and terminates at a first free end andforms a first valve leaflet-receiving area between the first anchor andthe first ring portion, and the second anchor has a second fixed endsecured to the second ring portion and terminates at a second free endand forms a second valve leaflet-receiving area between the secondanchor and the second ring portion; positioning the anchoring deviceproximate a native valve annulus; and rotating the first ring portionsuch that a first native valve leaflet enters the firstleaflet-receiving area.
 16. The method of claim 15, further comprisingrotating the second ring portion such that a second native valve leafletenters the second leaflet-receiving area.
 17. The method of claim 15,wherein the anchoring device has a prosthetic heart valve securedtherein, the prosthetic heart valve having a support frame and leafletswith the leaflets secured to the support frame to form a one-way valvestructure controlling fluid flow along the flow axis.
 18. The method ofclaim 15, wherein the first anchor and the second anchor each lie in thesame plane.
 19. The method of claim 15, wherein the first anchor and thesecond anchor each lie in a different plane.
 20. The method of claim 15,further comprising securing a prosthetic heart valve inside of theanchoring device.